Minskintercaps U.V. assumes responsibilities for the quality of drugs, assures their compliance with designation and requirements of registration file, risk failure for patients due to safety, quality and efficiency.
Quality assurance
Quality assurance system is introduced to implement quality standards and Good Manufacturing Practice and quality control. Quality assurance division of the enterprise includes departments dividing the functions of quality control and quality assurance:
- Chemico-microbiological laboratory;
- Process control department;
- Quality assurance department.
The departments are staffed with qualified specialists competent in test preparation and performance, Good Manufacturing Practice, quality assurance, the staff with specialized university education, professional training, technological knowledge and experience.
Quality control and quality assurance system established at the enterprise provides records and covers all the stages of manufacture and storage of products: essional training, technological knowledge and experience:
- Choice and evaluation of suppliers of API;
- Entrance control of raw material, excipients and packaging material;
- In-process product control;
- Bulk product inspection;
- Finish product inspection;
- Preparation of production room control;
- Process parameter control;
- Microbiological monitoring of production area (air, units, equipment, staff, overalls);
- Water quality control;
- Equipment cleaning control;
- Climatic control in production area and in magazines (temperature and humidity);
- Pressure drop control between production rooms;
- Validation[?] of drug manufacture (certification of production rooms, equipment and engineering systems, test method validation, validation of cleaning procedures and technological processes).
Chemico-microbiological laboratory
Chemico-microbiological laboratory of Minskintercaps U.V. has been accredited for technical competence in compliance with STB ISO/MEK 17025, Certificate N.BY/112 02.2.0.2743 dd. 11/07/2005.
The field of accreditation of the laboratory intends 34 test of drugs. The list of products under lab control of Minskintercaps U.V. covers 60 positions. The Laboratory is also responsible for entrance check of 90 positions of raw materials, i.e. pharmaceutical substances and excipients.
Minskintercaps Lab applies upgraded techniques to assure the compliance with Pharmacopoeia BY, EP and USP.
Identification, Assay, test of all main parameters of the quality of drugs, pharmaceutical ingredients and excipients is performed by test-methods of molecular and atomic spectrometry (Spectrophotometers HP 8453, Solaar M, Helios), liquid and gas chromatography (Liquid chromatographs Agilent 1100, gas Chromamtograph Agilent 6890, Liquid Chromatograph Nexera fitted with mass-spectrometry detector).
Functions and activities of Chemico-microbiological laboratory of Minskintercaps U.V.:
- Entrance control of pharmaceutical substances, primary packaging material, printed material;
- Physical and chemical tests of intermediate in bulk and finish products;
- Control of equipment cleaning for residuals of pharmaceutical substances, detergents and disinfectants;
- Physical, chemical and microbiological control of water treatment and water supply;
- Microbiological tests of raw material, finish products, primary packaging material, printed material;
- Control of microbial contamination of all the units in the production areas.